A Proof of Concept Study for the DNA Repair Driven by the Mesenchymal Stem Cells in Critical COVID-19 Patients
REPAIR
1 other identifier
interventional
30
1 country
2
Brief Summary
Our aim in this study is to determine the positive effect of stem cell therapy applied on critically ill patients with coronavirus infection on DNA repair genes. Patients diagnosed with COVID-19 infection are divided into two equal (n:30) groups. Group-1(n/15): Patients in critically ill condition receiving conventional therapy, Group-2 (n/15): Patients in critically ill condition receiving conventional therapy and systemically transplanted MSCs. The DNA repair pathway will be examined as 11 genes in 5 different parts. Investigated parameters:
- 1.Base excision repair
- 2.Nucleotide excision repair
- 3.Recombinational repair
- 4.Mismatch repair
- 5.Direct reversal Investigated parameters: broad biochemical analysis, apoptosis, clinical outcome, and mortality rates.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2020
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedFirst Submitted
Initial submission to the registry
May 21, 2021
CompletedFirst Posted
Study publicly available on registry
May 24, 2021
CompletedMay 24, 2021
May 1, 2021
8 months
May 21, 2021
May 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Expression of PARP1 gene as indicator of base excision repair
Expression of PARP1 gene as indicator of base excision repair
6 months
Expression of genes ATM, RAD51, RAD52 and WRN as indicator of Recombinational repair
Expression of genes ATM, RAD51, RAD52 and WRN as indicator of Recombinational repair
6 months
Expression of genes RAD23B and ERCC1 as indicator of Nucleotide excision repair
Expression of genes RAD23B and ERCC1as indicator of Nucleotide excision repair
6 months
Expression of genes MLH1, MSH2 and MSH6as indicator of Mismatch repair
Expression of genes MLH1, MSH2 and MSH6 as indicator of Mismatch repair
6 months
Study Arms (2)
Conventional Therapy
EXPERIMENTALConventional Therapy with Add-On MSC therapy
EXPERIMENTALInterventions
Mesenchymal Stem Cells Transplantation applied as three intravenous infusions with 30 days intervals
Eligibility Criteria
You may qualify if:
- years old male/female.
- Obtaining informed consent from him or his legal relative.
- Confirmed COVID-19 related severe ARDS cases.
You may not qualify if:
- pregnant, malignant tumours, the ones who has confirmed co-infection; history of using long-term immunosuppressive agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesilead
- Istinye Universitycollaborator
- Liv Hospital (Ulus)collaborator
Study Sites (2)
Istinye University
Istanbul, 34010, Turkey (Türkiye)
SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Istanbul, 34147, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2021
First Posted
May 24, 2021
Study Start
January 1, 2020
Primary Completion
August 30, 2020
Study Completion
September 30, 2020
Last Updated
May 24, 2021
Record last verified: 2021-05